Diabetes mellitus is a great threat to global health. Diabetes affects an estimated 171 million people worldwide. In 2014, the Centers for Disease Control and Prevention (“CDC”) estimated that 29.1 million people in the United States have diabetes. The CDC also reports that Type 2 diabetes accounts for 90 to 95 percent of diabetes cases.
Statistics show that diabetes disproportionately affects certain racial/ethnic populations. It has been reported that American Indians, Alaska Natives, African Americans, Hispanics or Latinos, Asian Americans, Native Hawaiians, and other Pacific Islanders have a higher prevalence of diabetes compared to non-Hispanic whites. For instance, the American Diabetes Association reports that 13.2 percent of all African Americans aged 20 years or older are diagnosed with diabetes, while 7.6 percent of non-Hispanic whites are diagnosed with diabetes.
Diabetes can lead to other serious local and systemic complications, including stroke, kidney disease, high blood pressure, ketoacidosis, gastroparesis, hyperosmolar hyperglycemic nonketotic syndrome (HHNS), neuropathy, poor circulation, retinopathy, cataracts, and glaucoma.
Type 2 diabetes can be diagnosed by a variety of conventional tests, including glycated hemoglobin (A1C), random blood sugar, fasting blood sugar, and oral glucose tolerance tests. These diagnostic tests require drawing a blood sample from the patient.
Saliva has recently been found to be a promising bodily fluid for diagnostic purposes. Saliva collection is non-invasive compared to phlebotomy and, as a result, may be more acceptable or convenient to patients. Further, because saliva collection is less invasive than phlebotomy, additional patients may seek diagnostic testing. Advantageously, it has been found that diagnostic tests using saliva can be just as effective as, and often even more effective than, blood-based tests because saliva samples can reflect real-time biomarker levels, unlike other biological fluids, such as urine which is stored in the bladder for a few hours before sampling.
It would be desirable to identify reliable saliva biomarkers for diabetes, particularly type 2 diabetes. Identification of such biomarkers may enable earlier detection of type 2 diabetes and provide more desirable testing options to patients.